Key Responsibilities:
- Overseeing the QA staff while supporting internal and client audits, as well as regulatory inspection of Quality Management Systems
- Maintain current knowledge of regulations, and training personal on good manufacturing practices applicable to all regulations
- Participating in compliance regulated activities within pharma development as well as cGMP manufacturing
- Informing oversight of deviations observed during the manufacturing, internal auditing, supplier and client audits as well as regulatory inspections
- Aiding in determining if any needed CAPA all while verifying that the designed actions are effective and implemented
- Establishing effective workflows, processes and metrics are in place to track compliance, effectiveness, and productivity.
- Manage and oversee assigned aspects of the Quality Assurance and Management System
- Ensuring that regulatory requirements, procedures, and processes are being held to the standard of the business
- Oversight of QA Staff
- Approving and reviewing regulatory documents
Key Requirements:
- Bachelor's Degree In relevant field
- experience in the pharmaceutical/biotech industry
- Compliance and Regulatory experience required
- Prior Management experience required
- Good Manufacturing Practice (GMP) experience
